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Oxaliplatin Therapy – scripted patients only

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Understanding your OXALIPLATIN therapy

Your doctor has assessed your condition and chosen OXALIPLATIN as part of the best treatment option for you.
This booklet has been designed to give you more information about cancer and the treatment that you will be receiving.

If you have any concerns about your treatment, do not hesitate to ask your doctor or nurse for help and advice.

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1. CANCER

Cancer is a disease in which healthy cells of the body become abnormal.1

Unlike healthy cells, cancerous cells:2

  • Multiply uncontrollably
  • Can get into and destroy normal body tissue
  • Can spread throughout your body

If the abnormal cell survives, it may divide into two, then four, then eight, etc. A group of abnormal cells then form. If this group of cells gets bigger, it becomes a large clump of abnormal cells called a tumour. Tumours may be benign (not cancerous and usually not lifethreatening) or malignant (cancerous).1

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CAUSES OF CANCER

The body has mechanisms that may protect us from developing cancer.
Damaged cells can repair themselves or your body’s immune system may be able to destroy some types of abnormal cells before they multiply into a tumour. We all have a risk of developing cancer.1
Although bowel cancer can develop for no apparent reason, there are certain risk factors which increase the chance that bowel cancer will develop.3
Risk factors include:3

  • Ageing: bowel cancer is more common in older people. Eight out of ten
    people who are diagnosed with bowel cancer are older than 60 years.
  • If a close relative has had bowel cancer (there is some genetic factor.)
    If you have familial adenomatous polyposis or hereditary non-polyposis bowel
    cancer. However, these are rare inherited disorders.
  • If you have ulcerative colitis or Crohn’s disease (conditions of the colon) for more than 8-10 years.
  • Lifestyle factors: Obesity, little exercise, drinking a lot of alcohol.
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2. COLORECTAL CANCER

What is the function of the colon and rectum?4
The colon and rectum make up the large intestine, which plays an important role in the body’s ability to process waste. The large intestine turns food digested by the stomach and small intestine into faecal waste (stool) that leaves the body through the anus.

Most colorectal cancers develop slowly over many years. Most of these cancers start as a polyp – a growth of tissue that starts in the lining and grows into the center of the colon or rectum. This tissue may or may not be cancer. A type of polyp, known as an adenoma, can become cancer. Removing a polyp early may keep it from becoming cancer. Over 95 % of colon and rectal cancers are adenocarcinomas. These are cancers that start in the cells that line the inside of the colon and rectum. There are some other, more rare, types of tumours of the colon and rectum.5

The stage is a way of describing a cancer, such as where it is located, if, or where it has spread, and whether it is affecting the functions of other organs in the body. There are five stages for colorectal cancer: stage 0 (zero) and stages 1 through IV.4

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HOW IS COLORECTAL CANCER TREATED?

The treatment of colorectal cancer depends on the size and location of the tumour, whether the cancer has spread, and the person’s overall health.3

Treatment options will usually combine therapies that:6

  • Act on the cancer locally, such as surgery or radiotherapy
  • Act on the cancer cells systemically (all over the body) such as chemotherapy and biologic therapy

The extent of the treatment will depend on the stage of the cancer, on the characteristics of the tumour and on the risks for the patient.

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3. ABOUT CHEMOTHERAPY

In this booklet we focus on chemotherapy using cytotoxic (anti-cancer) medication to kill cancer cells, or to stop them from multiplying.

Chemotherapy is increasingly being used for people with bowel cancer.

Radiotherapy is a treatment which uses high-energy beams of radiation which are focused on cancerous tissue. This kills cancer cells, or stops cancer cells from multiplying. It is most commonly used for bowel cancer when the tumour is in the rectum.

When chemotherapy or radiotherapy is used in addition to surgery it is known as adjuvant chemotherapy or adjuvant radiotherapy. For example, following surgery you may be given a course of chemotherapy or radiotherapy. This aims to kill any cancer cells which may have spread away from the primary tumour site.

Sometimes, adjuvant chemotherapy or radiotherapy is given before surgery, to shrink a tumour so that the operation to remove the tumour is easier and is more likely to be successful.

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4. ABOUT YOUR OXALIPLATIN TREATMENT

OXALIPLATIN belongs to the group of medicines called antineoplastics, which interferes with the growth of cancer cells to eventually destroy the cancer cells.
OXALIPLATIN is used to treat cancer of the rectum and colon. OXALIPLATIN is used in combination with other medicines to treat cancer.
OXALIPLATIN is used in combination with 5-fluorouracil and folinic acid in the treatment of metastatic colorectal cancer (cancer that has spread to other organs) and as adjuvant treatment of colon cancer (e.g. after surgery to the colon to remove the tumour).

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HOW IS OXALIPLATIN GIVEN?

OXALIPLATIN is for intravenous use only and must be diluted prior to use.
The dose of OXALIPLATIN will be different for different patients. Your doctor will decide on a suitable dose and the duration of your treatment based on your specific needs and medical condition.

You should not be administered OXALIPLATIN if you are hypersensitive (allergic) to OXALIPLATIN or any of the other ingredients; if you are pregnant or breastfeeding ; if your kidney function is severely weakened or you have a kidney disease and if you have a condition where the bone marrow does not make enough blood cells, or none at all.

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5. SIDE EFFECTS with OXALIPLATIN

OXALIPLATIN also affects the growth of normal cells, which may result in side effects. Some of these side effects may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some side effects may occur after treatment with OXALIPLATIN has been stopped.

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SIDE EFFECTS REQUIRING MEDICAL ATTENTION

Check with your doctor immediately if any of the following side effects occur:

  • Black tarry stools
  • Unusual bleeding or bruising
  • Sores, ulcers or white spots on lips or in mouth
  • Shortness of breath or wheezing
  • Painful or difficult urination
  • Blistering, peeling, redness and/or swelling of palms of hands or bottoms of feet
  • Rash
  • Rapid heartbeat
  • Sudden blindness or decreased vision
  • Hive-like swelling of face, eyelids, lips, tongue or throat
  • Severe stomach pain, cramps or diarrhoea.
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EFFECTS ON THE BLOOD & IMMUNE SYSTEM

OXALIPLATIN can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are needed for proper blood clotting.

If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • Try to avoid people with infections.
  • Be careful when using a regular toothbrush, dental floss or toothpick so as to not start bleeding.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using a sharp object such as a razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

Prior to each cycle of chemotherapy, it is usual to have a blood test to check on your ‘blood count’. This checks the level of your red blood cells, white blood cells and platelets. If these are too low, then a treatment cycle can be delayed or you may be given treatment to boost the levels of these blood constituents.

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COMMON, LESS SERIOUS SIDE EFFECTS INCLUDE

Nausea & Vomiting
It can be common to feel sick (nauseous) during and after each cycle of treatment.9
To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.

Hairloss9
Some cytotoxic medicines damage the hair cells. Some or all of your hair may fall out. This usually occurs 2-3 weeks after a course of treatment starts. Body hair and eyelashes may also fall out in addition to scalp hair. After the course of treatment has finished the hair will usually regrow within 4-12 months. You may wish to cut your hair short before starting chemotherapy so that any changes are not so dramatic. Some people like to wear a wig. Other people prefer to wear a hat or scarf. Remember to cover your head or wear high protection sun screen when out in the sun. If your eyelashes fall out, you can wear glasses or sunglasses to protect your eyes on windy days.

Constipation & Diarrhoea9
Constipation may be helped by eating plenty of foods high in fibre and increasing fluid intake. A laxative may be needed in some cases.
Diarrhoea is a side-effect from some medicines. You should increase your fluid intake if you develop diarrhoea. If it persists or becomes severe, you should tell your doctor. Anti-diarrhoeal medicines may be needed and you may even need to be admitted to hospital for treatment if you become dehydrated due to severe diarrhoea.
Drink 2 to 3 glasses of fluid every 24 hours, unless you were told to restrict your fluid intake, and maintain good nutrition. This will decrease your chances of being constipated, and prevent dehydration.8

Tiredness / Fatigue9
Tiredness is a common side-effect. It is likely that you will feel more tired than normal during a course of chemotherapy. You may need to cut back on your normal activities, plan regular rests, and if possible, take some regular light exercise. Some people feel overwhelmingly tired and may need to rely on other people to do routine daily chores.

Dizziness, Headache, Sneezing, Hiccups, Insomnia7

Nerve Problems (Neuropathy)7
OXALIPLATIN can affect nerves. This may lead to a lack of sensation in parts of the body such as the fingers or toes, resulting in pins and needles or weakness of muscles.

The use of cold drinks during infusion of OXALIPLATIN should be avoided, because cold temperature can worsen symptoms that affect nerves, for example tingling and/or numbness in the fingers, toes, around the mouth or in the throat.

Self care tips:8

  • While receiving treatment with OXALIPLATIN avoid cold temperatures and cold objects and don’t breathe deeply when exposed to cold air and don’t breathe deeply when exposed to cold air.
  • Cover yourself with a blanket while you receive your OXALIPLATIN infusion.
  • Wear warm clothing in cold weather at all times and cover your skin, mouth and nose if you must go outside in cold temperatures, to warm the air that goes into your lungs.
  • Do not drink cold drinks or use ice cubes in drinks, rather drink warm or room temperature drinks.
  • Avoid taking things from the freezer or refrigerator without wearing gloves.
  • Be aware that metals are cold to touch especially in the winter, so be sure to wear gloves to touch cold objects including your house door, car door, or mailbox.
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6. HOW TO LOOK AFTER YOURSELF WHILE ON CHEMOTHERAPY

Find out all you can about your cancer
Write down all the questions you have about your cancer so that you can ask them at your next appointment. Ask your health care team for reliable resources for further information about your diagnosis. The more you know about your cancer and your treatment options, the more confident you’re likely to feel.

Find someone to talk to
Find a trusted person you can talk to about how you’re feeling. Perhaps that person is a close friend or family member who is a good listener. Other people who can help include clergy members and counselors. Other people with cancer can offer unique insight.

Stay connected to family and friends.
Your family and friends provide an important support network for you during cancer treatment. Often family and friends want to help, but they aren’t sure how. Identify the support or help you need, even if it’s just someone being there to listen when you have a bad day. Offer these as suggestions when family and friends ask if there’s anything they can do to help.

Take care of yourself.
Do what you can to take care of yourself during cancer treatment. Eat a healthy diet full of fruits and vegetables. Get enough sleep so that you wake feeling rested. Find time for activities that can reduce stress, such as relaxation exercises, listening to music and writing your thoughts in a journal.

Medical References

1. Cancer – A general overview. Available at http://patient.info/health/cancer-a-general-overview. Accessed 25 May 2016
2. Cancer. Available at http://mayoclinic.com/health/cancer. Accessed 25 May 2016
3. Bowel (colorectal) cancer. Available at http://patient.info/health/bowel-colorectal-cancer. Accessed 25 May 2016
4. ASCO Answers. Available at http://www.cancer.net/about-us/about-asco/asco-patient-education-materials/asco-answers-factsheets.
Accessed 25 May 2016
5. American Cancer Society – Colorectal cancer overview. Available at http://www.cancer.org/cancer/colonandrectumcancer/
detailedguide/index. Accessed 25 May 2016
6. ESMO – Colorectal cancer : A guide for patients. Available at http://www.esmo.org/Patients/Patient-Guides/Colorectal-Cancer.
Accessed 25 May 2016
7. OXALIPLATIN PCH Approved Package Insert & Patient Information Leaflet
8. Chemocare : Oxaliplatin. Available at http://chemocare.com/chemotherapy/drug-info/Oxaliplatin. Accessed 25 May 2016
9. Chemotherapy with cytotoxic medicines. Available at http://patient.info/health/chemotherapy-with-cytotoxic-medicines
Accessed 25 May 2016
Refer to the package insert approved by the medicines regulatory authority for full prescribing information.
S4 OXALIPLATIN PCH 50. Each vial contains 50 mg Oxaliplatin per 10 ml. Reg. No.: 43/26/0102. Pharmacological classification:
A 26 Cytostatic agents.
S4 OXALIPLATIN PCH 100. Each vial contains 100 mg Oxaliplatin per 20 ml. Reg. No.: 43/26/0103. Pharmacological classification:
A 26 Cytostatic agents.
Applicant: Teva Pharmaceuticals (Pty) Ltd.

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